Medicinal vial and needle assembly



Z. M. ROEHR MEDICINAL VIAL AND NEEDLE ASSEMBLY Filed Oct. 13, 1959IIIIIIlIIIAZI/I a I Q 1 a 0 5 n n I M a Jan. 22, 1963 VIIIYIIIIIIJInventor zbislaw M-Roebr 15 wM,I.z-\A .Mu 8. NW

fl-l'kornefi United States Patent 33974541 MEEEEQENAL Vi'AL AND NEEDLEASdEP/EBLY Zbisiaw M. Roehr, Be Land, Fla, assi nor, by mesneassignments, to Brunswick Corporation, a corporation of Delaware iiiiedGet. 13, 1%59, Ser. N 846,115 6 Claims. (61. 266-43} The presentinvention relates generally to a vial-hypodeimic needle assembly, andmore particularly to an improved disposable medicinal vial-hypodermicneedle assembly and container therefor which maintains the sterility andprolongs the usefulness of the said assembly.

Various pre-assemblcd forms of a medicinal vial containing a medi amentand a hypodermic needle have been devised for use by the medical anddental professions. Generally, the medicinal vial comprises a length ofglass tubing which is sealably closed by a pierceable stopper at one endand by a moveable plunger disposed in the other end. Generally, themedicinal vial is maintained with the pierceable stopper end thereofspaced from the hypodermic needle but is readily moveable into piercingengagement with the said needle.

In a medicinal vial-hypodermic needle assembly of the foregoing type, itis difiicult to maintmn the operating parts thereof in a sterilecondition during packaging and prolonged storage periods. Anotherproblem frequently encountered in the packaging and distribution of avialneedle assembly is to prevent the hypodermic needle piercing theclosure stopper of the vial prematurely before the assembly isoperatively mounted in a hypodermic syringe, while at the same timeenabling the vial to be easily moved into piercing engagement with thehypodermic needle immediately prior to administration of the medicament.It is also important in a medicinal-vial needle assembly of theforegoing type to provide the assembly with means permitting aspirationafter the needle has been inserted into the patient and before injectionof the medicament.

Accordingly, it is an object of the present invention to provide animproved disposable medicinal vial-hypodermic needle assembly which canbe maintained in a sterile condition for prolonged periods of storage,and which meet the requirements of the medical and dental professions.

It is still another object of the present invention to provide animproved medicinal vial-hypodermic needle assembly which is lessexpensive and more convenient for use in a hypodermic syringe than thepreviously devised assemblies.

it is a further object of the present invention to provide an economicaland convenient medicinal vial-needle container assembly in which thehypodermic needle thereof can be more dependably maintained out ofpiercing engagement with the closure stopper of the medicinal vialduring storage and handling.

Other objects of the present invention will be apparent to those skilledin the art, from the following detailed description and accompanyingdrawing, wherein:

FIGURE 1 is a longitudinal vertical sectional view of the medicinalvial-hypodermic needle container assembly of the present invention;

FIG. 2 is an elevational view along the line 22 of FIGURE 1;

FIG. 3 is a longitudinal vertical sectional view of a modified form ofmedicinal via1-hypoderrnic needle container assembly;

FIG. 4 is a longitudinal vertical sectional view, partially in sideelevation, of a medicinal vial-hypodermic needle hub assembly of thepresent invention;

FIG. 5 is an enlarged fragmentary horizontal, vertical ectional view ofthe hypodermic needle hub shown in FIG. 4; and

?atenteri Jan. 22, 1953 FIG. 6 is a horizontal, vertical sectional viewof the medicinal vial-hypodermic needle assembly of the presentinvention operatively mounted in a hypodermic syringe.

With reference to the accompanying drawing, the improved medicinalvial-hypodermic needle assembly 1 of the present invention comprises ahypodermic needle unit 19 supporting in one end thereof a medicinal vialstructure 11, which together form a unitary assembly adapted to beremovably supported in a supporting container 12.

The hypodermic needle unit 10 comprises a vial sup porting hypodernucneedle hub member 20 having a stepped, generally cylindrical main bodysection 21, with preferably a stepped axial passage extendingtherethrough which is adapted to fixedly receive therein a double-endedhypodermic needle 23. The needle 23 has a small diameter cylindricalcollar or flanged ring section 24 swedged, or otherwise fixedly securedto the needle intermediate the ends thereof to provide an injection orflesh-piercing cannula 25 at one end and a closure piercing cannula 26at the other end. The ring section 24 is frictionally held in the axialpassage of the hub body section 21 so that the needle 23 does not moveaxially or rotatably with respect to the body section 21. Extendingforwardly from the mm'n body section 21 is an axially extending postsection 27 which is adapted to removably support thereon a cannulasheath 29 having, in the preferred form, a flanged end 3% for engagementwith a container wall. The hub body section 21 is also provided on theouter surface thereof with thread engageable means which is adapted toretain the hub member 29 in threadable engagement with a hypodermicsyringe.

Extending from the main hub body section 21, in an axial directionoppositely from the injection cannula 25', is a sleeve section 36symmetrically disposed about the closure piercing cannula 26 and adaptedto supportably retain therein the medicinal vial 11. The sleeve section36 has a diameter slightly smaller than the outer diameter of the vial11 but has sufficient inherent flexibility to yieldably and slidablyhold therein the vial 11. Adjacent the inner end of the sleeve section36 and spaced axially from the transverse end Wall 37 of the hub bodysection 21, are a plurality of radially inwardly extending resilientprojections 38, which define a vial abutting and retaining ring means.The sleeve section 36 with its inwardly extending projections 38 ispreferably formed of a resilient, yieldable plastic material, such asplasticized polyvinyl chloride or polyethylene. The sleeve 35 preferablyextends substantially beyond the end of the closure piercing stopper 26to enclose a substantial portion of the said vial 11, thereby providin"a bacterial seal therebetween to maintain the sterility of the closurepiercing cannula 26 and associated parts.

The medicinal vial 11 which is supported in the sleeve section 36 of thehub member 26 consists in general (FIG. 6) of a cylindrical member 44},such as a section of glass tubing, preferably having a restricted endsection. The cylindrical member 40 has the end opposite the restrictedsection 41 closed by a sealing plunger 42 reciprocably mounted therein.The cylindrical member 40 is sealed at the forwardly end by means of apierceable closure assembly which comprises a stopper 44 composed of aresilient elastomeric material, such as rubber, having a diametersufficient to engage the periphery of the reduced diameter end section41 and a retaining metal cap member 45 which has the lateral wallthereof crimped around the end section 41 and compresses the stopperagainst the end section 41 to form a sealing engagement therewith andleaving a reduced diameter transverse ring section 46 spaced axiallyfrom the end of the cap 45. The cap member 45 is preferably providedwith an axial opening 46 through which the closure piercing cannula 26 3passes when the vial 1 1 is moved into operative engagement therewith.

"The medicinal vial 11 is normally held within the sleeve 7 section 36with the closure assembly 43 maintained spaced longitudinally from theclosure piercing cannula 2.6. The latter spaced relationship is effectedby so arranging and proportioning the sleeve 36 and the projections 38that the vial 11 when inserted into the sleeve section 36 with the capmember 45 on the forwardly end; thereof. will abut the oroiections 38before the cap member 45 contacts the end of the closure piercingcannula 26 and will be restrained against further axial movement until asubstantially greater axial force is applied thereto. While the vial 11and needle unit 10 are normally frictionally held in the foregoingspaced assembled position, it is preferred-to provide locking means forpositively maintaining vial 11 and needle uni-t 10 int-he latter spacedassembledposition so that there is no likelihood of the vialbeingseparatedfrom the sleeve section 36'. Thus, a. short length ofpressure-sensitive tape 56 is preferablyplaced along the entire lengthof the line defining the juncture between the outer end of sleeve 36 andthe lateral surface of vial 11. An end tab 51 is provided to facilitateremoval of the tape 50. The tape 50, in addition to. preventing relativemovement between the vial 11- and the sleeve 36, also positivelyprevents bacterial contamination entering the, sleeve 36.

The medicinalvial-needle 11 'otthe, present invention is adapted tobeing removably; supported by a container structure 12,preferably.made.from a relatively yieldable plastic material such aspolyethylene, so as to avoid having any axial pressure applied to thevial 11 forcing the vial into closure piercing engagementwith thecannula 26 and causing the cannula 26 to enter the interior of vial 11.Thus, in the 'form shown in FIGURE 1 of the drawing, there is provided acylindrical container body section 60 having suificient strength toprotect the 'vial 11 against being crushed, and provided with an endwall 61 having an a'x'ial passage extending thereth-rough. The oppositeend-of the body section 60 has an unrestricted opening which permits thevial-needle assembly 1. being inserted therein. The inner diameter ofthe container body section 60 is substantially the same as-the externaldiameter of the sleevesection 36, whereby the sleeve 36 is. frictionallyand resiliently heldv inthe body section-60 when the assembly 1 isinserted therein. The axial passage in the end wall 61 is'soproportioned that it permits insertion therein of the cannula sheath 29until the cannula sheath 29' projects substantially beyond theend wall61 and so that the flanged end 30 of the sheath 29 is frictionallyengaged by the end wall 61 and is securely held within the'axialpassage. A- closure cap 65 is mounted'over the open end of the bodysect-ion 61 into abutment with a peripheral flange 66, thus completingthe container structure. The cap 65 and flange 66 are so proportionedand disposed that the cap does not forcethe vial 11 into piercingengagement with the cannula 26 which would effect entry thereof into theinterior of the vial 11. When the vial-needle assembly 1 is thus,positioned in the container body section 60 with the sheath 29frictionally engaged by the endwall 61 and the sleeve 36 frictionallyengaged -by the'inner wall surface of the container body section 60, thevial-needle assembly 1 is disposed entirely within the body section 60and securely held within the body section 69, thereby providing a safeand efiective protective container for the said assembly. 1 when the endcap section 65'is fitted over the open end of the body section 60.

"ln'the modified form of the container assembly shown in FIG; 3 of'thedrawing, the medicinal vial-hypodermic needle assembly comprises a vial11 slidably mounted in the sleeve36 of the needle hub body section 21which'is provided'with a slightly modified sheath member 70 removablymounted in: the: end oftheneedle hub; body section 21. The sheath 70 isprovided with an end flanged section 71 and an enlarged transversesection 72 spaced axially a short distance outwardly from the endflanged section 71. The sheath section 70 of the said vial-needleassembly is adapted to be inserted into the cap member 73 until theflanged section 71 frictionally engages the. inner surface of thetransverse end Wall 74 of the cap meme. ber 73. When so disposed, thesheath 71 is restrained against axial inwardly movement relative to thesaid cap member 73 by the enlarged section 72 frictionally engag ing theouter surface of the end wall 74. The vial-needle assembly is thusrestrained against being accidentally separated from the cap member 73,or being moved in= wardly toward the left by accidental contactbeingmade with the sheath 70. The vial-needle assembly is then inserted intoposition within the container body section 76 by mounting the cap member73 on the end of the container body section 76..

Whenthe medicinal vial-needle assembly '1 is to be used, theassembly isremoved from the supporting con: tainer structure described hereinwithoutremoving the protective sheath from the hubsection'. Thevial-needle assembly is then mounted in, a standard Tubex typesyringe80, as shown in FIG. 6, wherein the vial-needle.

assembly is inserted into the tubular barrel section 81 of the syringewhich is-provided with the usual longitudinal lateralopenings while thepivotally mountedhead section. 83 is movedto one side. The vial-needleas: sembly 1 is. threadably engaged with the internally threaded sectionat the lower end of the syringe barrel 81 by rotatingthe vial-needleassembly until the thread engageable means 35 of the hubbody section 21operatively engage the threaded section 85. The. plunger rod 84 mountedin the head section 33 and having a thumb-rest-piece sfi at the outerend/thereof is then op= eratively. engaged at its inner end with theplunger 42 of the vial 11. The plunger 42 is preferably provided withthreadable means for engagement with the piston rod 8r4 to permitinwardly and outwardly movement of the plunger 4-2, whereby aspirationcan be performed after the injection cannula 25isinserted' into thepatient and before injection of the medicament. Before'aspiration orrnsertion of the said cannula 25 into the patient, the vial 11 1s fullyseated by moving the vial forwardlyv in the sleeve 36 until the closurepiercing cannula 26 pierces the stopper 44 to efiect communication withtheinterior of the vial 11 and the end of the closure assembly abutstheend wall 37, whereuponthe vial '11 is locked in the sleeve 36. Thelocking action between the vial 11 and the sleeve 36 1s effected whenthe vial 11 is fully seated in the sleeve 36 by means of theprojections-38 resiliently engaging the reduced diameter section 46 ofthe vial 11. The pro ections 38 thus restrain the axial movement of thevial 11 when the piston rod'84 and plunger 42 are moved outwardly duringaspiration. I

The improved medicinal vial-hypodermic needle-assembly of the presentinvention is preferably supplied by the pharmaceutical manufacturer inthe forms shown in'FIGS. Land 3. If preferred, however, the assemblycanbe shipped in the form shown in FIG. 4. It should be understood thatthe pharmaceutical manufacturer will, under normal conditions, obtainthe hypodermic needle hub member 20 of the present invention separatelyfrom the medicinal vial 11 which must be filled with the desiredmedicament by the pharmaceutical manufacturer and thereafter assembled,as described herein, with the hub section and the supporting container.

Others may practice the invention in any of the numer ous ways which aresuggested to one skilled in the art, by this disclosure, and all suchpractice of invention are considered to be a part hereof which fallwithin the scope of the appended claims.

I claim:

1. A disposable medicinalvial and needle assembly for insertion as aunit in a cartridge-type hypodermic syringe comprising, a hypodermicneedle hub section provided with an axial passage extendingtherethrough, a doubleended hypodermic needle fixedly mounted in saidaxial passage with an injection cannula extending therefrom in onedirection and a closure piercing cannula extending in the oppositedirection, a protective sheath removably connected with the said hubsection enclosing the said injection cannula, said hub section havingthereon means for being detachably secured to a cartridge-typehypodermic syringe, a sleeve section formed integrally with said hubsection and extending axially from the hub section, said sleeve sectionbeing disposed symmetrically about said closure piercing cannula andprojecting axially substantially beyond the end of said piercingcannula, said sleeve section adapted to yieldably engage a substantialarea of the lateral surface of a medicinal vial disposed in said sleevesection to provide a bacterial seal therebetween a medicinal vialslidably disposed in said sleeve section and normally spaced from saidpiercing cannula but moveable axially into piercing engagement with saidcannula, and said assembly adapted to be fixedly mounted as a unitwithin a barrel of said cartridge-type hypodermic syringe.

2. A medicinal vial and needle assembly as in claim 1, wherein the saidsleeve section resiliently engages the lateral surface of the said vialalong the entire circumference thereof and extends in resilient slidingengagement therewith axially about half the length of said vial, therebyforming a bacteria impervious barrier to maintain the sterility of saidclosure piercing cannula.

3. A medicinal vial and needle container assembly, comprising ahypodermic needle hub section provided with a hypodermic needle mountedaxially therein, said needle having one end forming an injection cannulaand the other end forming a closure piercing cannula, a sleeve sectionformed integrally with said hub section and extending axially from thesaid hub section disposed symmetrically about the said piercing cannulaand adapted to receive therein a medicinal vial, a medicinal vialmounted in said sleeve section and adapted to be operatively connectedwith the said hypodermic needle, a protective sheath member removablyconnected with the said hub section enclosing said injection cannula, acontainer adapted to removably support therein the said vial and needleassembly and frictionally engage the said sleeve section with themedicinal vial supported therein without contacting said medicinal vial,said container being provided with an axial passage in one end wallthereof which frictionally and sealably engages the said sheath adjacentthe hub section with which the said sheath is associated, whereby thesaid needle and hub assembly is removably and sealably supported withinthe said container body.

4. A medicinal vial and needle container assembly as in claim 3, whereinthe said container is comprised of a closure cap member and a main bodysection adapted to frictionally engage the said sleeve section with atransverse end wall at one end thereof provided with said axial passagefor sealably receiving therein said sheath, and a closure cap memberremovably and sealably mounted on the opposite end of said main bodysection.

5. A medicinal vial and needle container assembly as in claim 3, whereinthe said container is comprised of a closure cap member and a main bodysection adapted to frictionally engage said sleeve section, said closurecap member removably mounted on the other end of the said body section,and said ClOSlll'B cap member having one end thereof provided with saidaxial passage for sealably receiving therein said sheath.

6. A disposable hypodermic needle assembly for insertion as a unit in abarrel of a cartridge-type hypodermic syringe and adapted to slidablyretain therein a medicinal vial comprising, a hypodermic needle hubhaving an axial passage extending therethrough, a double-endedhypodermic needle fixedly mounted in said axial passage with aninjection cannula extending in one direction and a closure piercingcannula extending in the opposite direction, a protective sheathremovably connected with the said hub enclosing said injection cannula,said hub having thereon means for being detachably secured to acartridgetype hypodermic syringe, a sleeve section formed integrallywith said hub section and extending axially from the hub disposedsymmetrically about said closure piercing cannula and projecting axiallysubstantially beyond the end of said piercing cannula, and said sleevesection being resilient and adapted to slidably and sealably retaintherein a medicinal vial to form an integral unit which is adapted to bedetachably mounted as a unit in said barrel of said cartridge-typehypodermic syringe.

References Cited in the file of this patent UNITED STATES PATENTS2,728,341 Roehr Dec. 27, 1955 2,828,743 Ashkenaz et a1. Apr. 1, 19582,842,126 Brown July 8, 1958 FOREIGN PATENTS 720,652 Great Britain Dec.22, 1954 818,956 France June 28, 1937

3. A MEDICINAL VIAL AND NEEDLE CONTAINER ASSEMBLY, COMPRISING AHYPODERMIC NEEDLE HUB SECTION PROVIDED WITH A HYPODERMIC NEEDLE MOUNTEDAXIALLY THEREIN, SAID NEEDLE HAVING ONE END FORMING AN INJECTION CANNULAAND THE OTHER END FORMING A CLOSURE PIERCING CANNULA, A SLEEVE SECTIONFORMED INTEGRALLY WITH SAID HUB SECTION AND EXTENDING AXIALLY FROM THESAID HUB SECTION DISPOSED SYMMETRICALLY ABOUT THE SAID PIERCING CANNULAAND ADAPTED TO RECEIVE THEREIN A MEDICINAL VIAL, A MEDICINAL VIALMOUNTED IN SAID SLEEVE SECTION AND ADAPTED TO BE OPERATIVELY CONNECTEDWITH THE SAID HYPODERMIC NEEDLE, A PROTECTIVE SHEATH MEMBER REMOVABLYCONNECTED WITH THE SAID HUB SECTION ENCLOSING SAID INJECTION CANNULA, ACONTAINER ADAPTED TO REMOVABLY SUPPORT THEREIN THE SAID VIAL AND NEEDLEASSEMBLY AND FRICTIONALLY ENGAGE THE SAID SLEEVE SECTION WITH THEMEDICINAL VIAL SUPPORTED THEREIN WITHOUT CONTACTING SAID MEDICINAL VIAL,SAID CONTAINER BEING PROVIDED WITH AN AXIAL PASSAGE IN ONE END WALLTHEREOF WHICH FRICTIONALLY AND SEALABLY ENGAGES THE SAID SHEATH ADJACENTTHE HUB SECTION WITH WHICH THE SAID SHEATH IS ASSOCIATED, WHEREBY THESAID NEEDLE AND HUB ASSEMBLY IS REMOVABLY AND SEALABLY SUPPORTED WITHINTHE SAID CONTAINER BODY.